Regulatory Operations Manager to AstraZeneca Gothenburg
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
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hela Sverige About AstraZeneca
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We now have a temporary position as a Regulatory Operations Manager to our site in Gothenburg, Sweden for an approximately half year assignment.
The Regulatory Operations Manager (ROM) is an expert in end-to-end document and submission publishing. The ROM is also an expert in understanding Health Authority requirements as well as the regulatory requirements regarding technical and formatting aspects of global regulatory submission publishing.
Essential Requirements:
• Experience of system administration for validated applications within a regulated environment.
• Experience from analysing queries from the user community to identify improvement opportunities in Systems, Cue Cards, - Training Materials and business processes.
• Demonstrated ability to work collaboratively in a global team environment and to have good project management skills.
• Demonstrates a broad working knowledge of process improvement methodologies, tools, techniques and their application.
• Excellent English written and verbal communication skills.
Desirable Requirements:
• Demonstrated ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment.
• Ability to use project management principles and techniques.
Experience from planning, preparation and delivery of regulatory submissions. Providing support to users with questions related to document and submission publishing.
• Experience from evaluating regulations, guidelines and technical specifications related to publishing/submission processes.
• Experience in pharmaceutical/medical industry and/or knowledge of the drug development process, product life-cycle and contents/formatting of regulatory submissions.
• Experience from electronic document managements systems.
• Good problem and conflict resolution skills.
About ALTEN
For over 20 years, ALTEN has developed its business by keeping to the core values that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Rickard Westergren, Business Manager Pharma, at
rickard.westergren@alten.seVaraktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-12-04ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-12-11
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4491830
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